Dexamethasone

Product NDC: 67296-0326
Requested package NDC: 67296-0326-1
11-digit product format: 672960326
Labeler code: 67296
Product ID: 67296-0326_d5fbe823-eb13-76fa-e053-2a95a90ae7b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug
Application: ANDA084612
Marketing category: ANDA
Marketing start: 2018-01-01
Marketing end: 0000-00-00
Substance: DEXAMETHASONE
Active strength: 4 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-0326	67296-0326-1	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0326	67296-0326-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0326	67296-0326-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0326	67296-0326-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084612-001	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-002	DEXAMETHASONE	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-003	DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-004	DEXAMETHASONE	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15
A084612-005	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-006	DEXAMETHASONE	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A084612-007	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A084612-001	AB
A084612-002	AB
A084612-003	AB
A084612-004	AB
A084612-005	AB
A084612-006	AB
A084612-007	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 65 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	BP	Approved before 1982		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	Approved before 1982		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	BP	Approved before 1982		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	BP	Approved before 1982		`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 65 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084612-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084612-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084612-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084612-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084612-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084612-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084612-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084612-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084612-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084612-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084612-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084612-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084612-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084612-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084612-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084612-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084612-001	BP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084612-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084612-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084612-001	BP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084612-001	BP	1	`5aa47cf7b7d7…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-0326-1	2024-06-19	C162847	48780-1	1030e365-5c76-111a-e063-dadaa90a10e2	dexamethasone 4mg
67296-0326-1	2024-01-30	C162847	48780-1	1030e365-5c76-111a-e063-dadaa90a10e2	dexamethasone 4mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0326-1	Dexamethasone	10 in 1 BOTTLE	TABLET	10		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0326	DEXAMETHASONE TABLET [REDPHARM DRUG]	6	Legacy NDC, 1 package rows	20240620_674fd223-fd39-e608-e053-2991aa0a9bdc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	REMEDYREPACK INC.	f5c9b70b-b835-4f3b-9643-0aec50a0d3f2	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	89e1d458-7caa-430f-9c54-360889899a73	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Cardinal Health 107, LLC	bf8acfdb-8dc8-4a69-90b0-33c680c421d6	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Northwind Health Company, LLC	aa30086a-8551-413e-9cf2-6393093cfcfd	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Golden State Medical Supply, Inc.	a7455c92-41ce-4e87-e053-2995a90a610f	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Hikma Pharmaceuticals USA, Inc.	b15200fb-1826-472b-a907-e677a272513b	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
DEXAMETHASONE	DEXAMETHASONE	Direct Rx	cc7140de-a205-f675-e053-2995a90ac22b	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	99296e80-3ca6-4430-9ef7-adca357c31b3	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Doc Rx	f1c30431-554b-4161-9d8c-5795c689e0bd	2021-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	89e570c9-3e64-433b-9779-b94332f2b5ef	2020-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197582	dexAMETHasone 4 MG Oral Tablet	PSN	674fd223-fd39-e608-e053-2991aa0a9bdc	6
197582	dexamethasone 4 MG Oral Tablet	SCD	674fd223-fd39-e608-e053-2991aa0a9bdc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0326-1	67296032601	10 TABLET in 1 BOTTLE (67296-0326-1)	10 tablet	2018-01-01	0000-00-00	No	No	Current